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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K082720
FOIA Releasable 510(k) K082720
Device Name TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
Applicant
Olympus Medical Systems Corporation
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Applicant Contact STACY ABBATIELLO KLUESNER
Correspondent
Olympus Medical Systems Corporation
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact STACY ABBATIELLO KLUESNER
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received09/17/2008
Decision Date 11/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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